Report

November 6

What does the new TPPI guidance mean to ENDS companies?

Broughton Nicotine Services Director of Product Safety and Compliance, Yvonne Wilding, looks at the recent Tobacco Product Perception and Intention studies (TPPI) guidance issued by FDA

Yvonne discusses the TPPI guidance and reflects that while it may be a little too late for some companies, the guidance offers useful insights into FDA thinking on this topic.

FDA TPPI Guidance

Food and Drug Administration (FDA) recently issued a guidance for industry document on the ‘Principles for Designing and Conducting Tobacco Product Perception and Intention studies', read the Guidance document here. This guidance document may unfortunately come a little too late for those companies who have already submitted Premarket Tobacco Product Applications (PMTAs) and may have received or are expecting to receive deficiency letters for either the lack of, or the unsuitability of, the behavioural studies that they have submitted for review. Nonetheless, for those companies who are planning to submit a PMTA or a Modified Risk Tobacco Product Application (MRTP) or for those dealing with known deficiencies, the guidance is very welcome as it provides insight into the current thinking of FDA.

Protection of Public Health

One of the important aspects of a PMTA submission is demonstration of the product’s appropriateness for the protection of public health (APPH) which covers not only the safety and health impacts associated with inhaled exposure to the product, whether that be a device, and e-liquid, or both, but also how the product affects people’s perceptions of tobacco products and whether they may feel inclined to use the product. A flag of concern would be if the product appealed to previous non-smokers as this may increase the prevalence of nicotine addiction and adversely affect public health.

Behavioural Science

FDA recommends that behavioural studies should look at primary and secondary endpoints and stresses the importance of ensuring studies are sufficiently robust and have an appropriate sample size to detect what may be potentially subtle differences in behaviour or perception. The FDA describes the types of studies that can be conducted with either qualitative or quantitative methodology over several different study designs including experimental, longitudinal, and cross-sectional. FDA do not preclude manufacturers from presenting their own study design approaches but strongly advise adoption of existing best practices and recommend interaction with well-established behavioural science organizations and individuals with proven expertise in behavioural science. FDA also encourages manufacturers to meet with FDA to discuss their proposals for behavioural study investigations, although how many organizations have taken up the offer with FDA and have been able to receive timely feedback is not known.

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About the Author

Yvonne Wilding is the Director of Product Safety and Compliance. She has over 10 years of broad regulatory toxicology experience and 20 years of pharmaceutical drug development Research & Development leadership. She has been responsible for numerous MAA and NDA submissions, for both small molecules and biologics and has experience stretching from early candidate selection through life cycle management of new medicines. Her toxicology experience was gained with GlaxoSmithKline's (GSK) large portfolio of respiratory products in a specialized inhalation toxicology department. Yvonne began her career as a regulatory toxicologist for GSK responsible for designing the strategic drug safety evaluation programs to satisfy all global markets using both in-vivo and in-vitro approaches; for operational delivery both with an in-house team and with Contract Research Organisations (CRO). This involved working closely with clinical teams and key opinion leaders to ensure patient safety at each stage of development. She has extensive experience of interacting with regulatory agencies. Following on from Toxicology, Yvonne was responsible for managing and leading drug development programs encompassing all functional disciplines to ensure delivery of successful marketing applications and to maximise the commercial opportunity for each product. Yvonne’s clinical experience encompasses clinical program strategy, study management, clinical portfolio management and pharmacovigilance. Most recently, Yvonne worked with AstraZeneca in the Precision Medicine department to develop new diagnostic tests and submit PMA applications for companion diagnostics devices evaluating genetic biomarkers of disease susceptibility in collaboration with major diagnostic companies.